Status:
COMPLETED
FEnofibRate as a Metabolic INtervention for COVID-19
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
University of Arizona
Universidad Católica de Santa María
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The severe acute respiratory syndrome coronavirus 2 (SARS-CoC-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndr...
Eligibility Criteria
Inclusion
- A diagnosis of COVID-19, based on: (a) A compatible clinical presentation with a positive laboratory test for SARS-CoV-2, or (b) Considered by the primary team to be a Person Under Investigation undergoing testing for COVID-19 with a high clinical probability, in addition to compatible pulmonary infiltrates on chest x-ray (bilateral, intersticial or ground glass opacities) or chest CT.
- Able to provide informed consent.
- Fewer than 14 days since symptom onset.
Exclusion
- Known pregnancy or breastfeeding
- Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 or undergoing dialysis (CKD stages 4-5).
- History of active liver disease, cholelithiasis, uncontrolled hypothyroidism, or rhabdomyolysis (suspected or confirmed). Patients with a history of hypothyroidism receiving a stable dose of thyroid replacement therapy for at least 6 weeks, with a documented normal TSH (primary hypothyroidism) or free thyroxine (secondary or tertiary hypothyroidism) level at least 6 weeks after the last dose change will be considered eligible for enrollment.
- Known hypersensitivity to fenofibrate or fenofibric acid.
- Ongoing treatment with fenofibrate, clofibrate, warfarin and other coumarin anticoagulants, glimepiride, cyclosporine, tacrolimus
- Use of statins other than simvastatin, pravastatin or atorvastatin ≤40 mg/d or rosuvastatin ≤20 mg/d
- Prisoners/incarcerated individuals
- Inability to read, write or no access to a smart phone, computer or tablet device
- Intubated patients.
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
701 Patients enrolled
Trial Details
Trial ID
NCT04517396
Start Date
August 18 2020
End Date
March 30 2022
Last Update
March 24 2023
Active Locations (1)
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1
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104